Abstract

A randomized clinical trial of maternal-fetal HIV transmission is proposed which will directly compare the efficacy of AZT alone with AZT + 3TC in 1200 HIV-infected Indian women enrolled over a period of 24 months. In addition, the effect of length of therapy will also be assessed: more than 40% of this cohort will be enrolled after 36 weeks of gestation and 30% will be enrolled when they present in labor. This study will also compare the rates of post-partum maternal viral AZT resistance and the morbidity and mortality of mother/infant pairs in the 2 treatment arms. In addition, this study will characterize factors that promote women's participation in clinical trials to assist future trials, as well as implementation of clinical and behavioral HIV prevention interventions. This study will provide an opportunity to identify and design future interventions, and could more rapidly focus resources on specific causes of postpartum morbidity and mortality for mothers and infants in developing countries.

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Type
Research Project (R01)
Project #
5R01AI045462-03
Application #
6374160
Study Section
Special Emphasis Panel (ZRG1-AARR-6 (01))
Program Officer
Soto-Torres, Lydia E
Project Start
1999-09-01
Project End
2003-08-31
Budget Start
2001-09-01
Budget End
2002-08-31
Support Year
3
Fiscal Year
2001
Total Cost
$1,770,269
Indirect Cost

  Institution

Name
Johns Hopkins University
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
045911138
City
Baltimore
State
MD
Country
United States
Zip Code
21218

  Publications

Kinikar, Aarti; Gupte, Nikhil; Bhat, Jayalakshmi et al. (2017) Maternal Syphilis: An Independent Risk Factor for Mother to Infant Human Immunodeficiency Virus Transmission. Sex Transm Dis 44:371-375
Shivakoti, Rupak; Gupta, Amita; Ray, Jocelyn C et al. (2016) Soluble CD14: An Independent Biomarker for the Risk of Mother-to-Child Transmission of HIV in a Setting of Preexposure and Postexposure Antiretroviral Prophylaxis. J Infect Dis 213:762-5
Mave, Vidya; Erlandson, Kristine M; Gupte, Nikhil et al. (2016) Inflammation and Change in Body Weight With Antiretroviral Therapy Initiation in a Multinational Cohort of HIV-Infected Adults. J Infect Dis 214:65-72
Mave, V; Chandanwale, A; Bhosale, R et al. (2015) Vitamin D deficiency and risk of postpartum tuberculosis among HIV-infected breastfeeding mothers in India. Int J Tuberc Lung Dis 19:302-4
Tenforde, Mark W; Gupte, Nikhil; Dowdy, David W et al. (2015) C-reactive protein (CRP), interferon gamma-inducible protein 10 (IP-10), and lipopolysaccharide (LPS) are associated with risk of tuberculosis after initiation of antiretroviral therapy in resource-limited settings. PLoS One 10:e0117424
Havers, Fiona P; Detrick, Barbara; Cardoso, Sandra W et al. (2014) Change in vitamin d levels occurs early after antiretroviral therapy initiation and depends on treatment regimen in resource-limited settings. PLoS One 9:e95164
Mave, V; Kadam, D; Kinikar, A et al. (2014) Impact of maternal hepatitis B virus coinfection on mother-to-child transmission of HIV. HIV Med 15:347-54
Gupta, Amita; Mathad, Jyoti S; Yang, Wei-Teng et al. (2014) Maternal pneumococcal capsular IgG antibodies and transplacental transfer are low in South Asian HIV-infected mother-infant pairs. Vaccine 32:1466-72
Havers, Fiona; Smeaton, Laura; Gupte, Nikhil et al. (2014) 25-Hydroxyvitamin D insufficiency and deficiency is associated with HIV disease progression and virological failure post-antiretroviral therapy initiation in diverse multinational settings. J Infect Dis 210:244-53
Mathad, Jyoti S; Gupta, Amita (2012) Tuberculosis in pregnant and postpartum women: epidemiology, management, and research gaps. Clin Infect Dis 55:1532-49

Showing the most recent 10 out of 32 publications